Indian Pharma Sector: Evolving to Innovation

The enactment of the Indian Patents Act of 1970, implemented in 1972, provided an open platform to the Indian pharmaceutical industry to adopt process patents to manufacture active pharmaceutical ingredients (APIs) and formulations without fear of infringement of product patents. This resulted in a phenomenal growth in the number of pharmaceutical manufacturing units, from 2257 in 1970, to 5156 in 1980, 16,000 in 1990, and more than 23,000 in 2005. This was accompanied by a steep increase in investment from Rs. 2.25 billion (approx. $250 million US) in 1973, to Rs. 45 billion (approx. $1 billion US) in 2002–03. The prices of the most advanced drugs dropped significantly in India, leading the Indian pharma sector to become more competitive while remaining extremely cost effective in the global market.

Companies Interviewed

These advantages, however, came with the major drawback of not recognizing the importance of new drug discovery in the Indian pharmaceutical sector, thus creating the conditions for a lack of scientific knowledge, personnel, and processes required for successful new drug discovery. However, significant contributions from the Indian pharmaceutical industry, which include the most innovative manufacturing units, developing the most cost-effective processes, and exceptional medicinal chemistry knowledge, have been recognized globally. India's becoming a signatory to the World Trade Organization (WTO) in 1995, and the recent implementation of product patents, have brought about a paradigm shift from process to product innovation and have compelled major Indian pharmaceutical industries to invest in new drug discovery.

Discovering new drugs: an Indian scenario

The first new drug discovery center in India was started by Ciba-Geigy in the early seventies, followed by Hoechst, Boots, and AstraZeneca. Ciba-Geigy and Boots decided to close their R&D ventures, while the Indian company Nicholas Piramal acquired Hoechst's center. Presently, AstraZeneca is the only multinational corporation (MNC) that has drug discovery operations in India. It is essential to recognize that these operations were initiated when Astra was an independent company and were supported jointly by the Indian Government to conduct research on tuberculosis It is also interesting to analyze why, despite implementation of product patent law, multinational companies have not invested into drug discovery in India.

A survey conducted by the Department of Science and Technology in 2002 suggested that the R&D activities of MNC subsidiaries are minimal in India and mainly directed towards formulation development or troubleshooting. This is demonstrated by the fact that R&D expenditure by Indian Pharmaceutical companies stands at 2.6%, which is three and a half times more than MNC R&D, which is low and static at 0.74%. Initially, the cost of drug discovery in India, which is one-tenth of the cost of discovery in the West, was expected to be a major attracting factor for MNCs to establish their R&D efforts in India. This has not been the case, as there are multiple factors responsible for deterring MNCs from initiating drug discovery in India.